Safety Study of Three Formulations of the Dermal Implant ELAPR

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ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.

Other Names:

Other Names:

Tropoelastin 0.1ml SC implant

Device: ELAPR

Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003

Other Name: Tropoelastin 0.1ml SC implant

Active Comparator: ELAPR002

Tropoelastin 0.1ml SC implant

Device: ELAPR

ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.

Other Names:

Other Names:

Tropoelastin 0.1ml SC implant

Device: ELAPR

Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003

Other Name: Tropoelastin 0.1ml SC implant

Active Comparator: ELAPR003

Tropoelastin 0.1ml SC implant

Device: ELAPR

ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.

Other Names:

Other Names:

Tropoelastin 0.1ml SC implant

Device: ELAPR

Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003

Other Name: Tropoelastin 0.1ml SC implant

Placebo Comparator: Saline

Normal Saline 0.9%

Device: ELAPR

ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.

Other Names:

Other Names:

Tropoelastin 0.1ml SC implant

Device: ELAPR

Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003

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